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The AMS Spectra™ Concealable Penile Prosthesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery. These devices are contraindicated in patients who: have active urogenital infections or active skin infections in the region of surgery; patients whose proximal corporal length measurements is less than the proximal rigid section of the Spectra cylinders, or whose total intracorporal length is not within the range of 12 cm to 27.5 cm; patients who require repeated endoscopic procedures; or patients who have compromised tissue and as a result cannot withstand constant pressure.
Implantation will make latent natural or spontaneous erections, as well as other interventional treatment options, impossible. Men with diabetes, spinal cord injuries or open sores may have an increased risk of infection. Failure to evaluate and treat device erosion may result in infection and loss of tissue. Implantation may result in penile shortening, curvature, or scarring. Possible adverse events include, but are not limited to: infection, erosion, migration, extrusion, mechanical malfunction, patient dissatisfaction, adverse tissue reaction, allergic reaction, pain, urinary obstruction, and silicone particle migration.
Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, and potential adverse events.